(28 days)
Measures automatically human beings Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD panel.
The intended for use of this over-the-counter device is for adult patients with arm circumference between 24cm-44cm (approx. 9.4" to 17.5").
Not Found
Please note: The provided document is a 510(k) clearance letter from the FDA. It does not contain the detailed study information (acceptance criteria, sample sizes, ground truth methods, MRMC studies, etc.) that would typically be found in a submission or a clinical study report. The letter confirms that the device, an H&L Full Automatic (NIBP) Blood Pressure Monitor, has been found substantially equivalent to a predicate device.
Therefore, the following response will indicate where information is not present in the provided document.
Acceptance Criteria and Study Details for H&L Full Automatic (NIBP) Blood Pressure Monitor (HL888KM, HL888DM)
The provided FDA 510(k) clearance letter (K050587) confirms that the H&L Full Automatic (NIBP) Blood Pressure Monitor is substantially equivalent to a predicate device. However, this letter does not contain the specific acceptance criteria or the detailed description of the study that demonstrated the device met these criteria.
To provide a hypothetical example of what such information might look like for a non-invasive blood pressure (NIBP) monitor, and based on common regulatory and industry standards like ISO 81060-2 (which specifies requirements for clinical validation of NIBP devices), the following sections are structured to show what would typically be expected in a complete submission.
1. Table of Acceptance Criteria and Reported Device Performance
(This information is NOT present in the provided 510(k) clearance letter. The table below provides an example of typical acceptance criteria for a non-invasive blood pressure monitor based on standards like ISO 81060-2, and hypothetical performance values.)
| Acceptance Criterion (Example based on ISO 81060-2) | Device Performance (Hypothetical) | Status |
|---|---|---|
| Criterion 1: Mean Difference (Bias) | ||
| Mean difference between device and reference measurement for SBP ≤ ±5 mmHg | SBP: +0.8 mmHg | Met |
| Mean difference between device and reference measurement for DBP ≤ ±5 mmHg | DBP: -0.5 mmHg | Met |
| Criterion 2: Standard Deviation of Differences | ||
| Standard deviation of differences for SBP ≤ 8 mmHg | SBP: 6.2 mmHg | Met |
| Standard deviation of differences for DBP ≤ 8 mmHg | DBP: 5.7 mmHg | Met |
| Criterion 3: Individual Differences | ||
| Percentage of differences within ±5 mmHg for SBP ≥ 80% | SBP: 88% | Met |
| Percentage of differences within ±5 mmHg for DBP ≥ 80% | DBP: 85% | Met |
| Percentage of differences within ±10 mmHg for SBP ≥ 90% | SBP: 96% | Met |
| Percentage of differences within ±10 mmHg for DBP ≥ 90% | DBP: 94% | Met |
| Percentage of differences within ±15 mmHg for SBP ≥ 95% | SBP: 99% | Met |
| Percentage of differences within ±15 mmHg for DBP ≥ 95% | DBP: 98% | Met |
2. Sample Size Used for the Test Set and Data Provenance
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Sample Size (Test Set): This information is not provided in the 510(k) clearance letter.
- (Hypothetical Example based on ISO 81060-2: Typically, a clinical validation study for an NIBP device would require a minimum of 85 participants for accuracy testing, with careful consideration for age, gender, arm circumference, and blood pressure ranges to ensure a representative sample.)
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Data Provenance: This information is not provided in the 510(k) clearance letter.
- (Hypothetical Example: "Prospective data collected at a single clinical site in Taiwan. Participants were recruited based on inclusion/exclusion criteria to ensure a diverse range of blood pressures and arm circumferences.")
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
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Number of Experts: This information is not provided in the 510(k) clearance letter.
- (Hypothetical Example based on NIBP validation standards: Typically, two trained observers are used for simultaneous auscultatory measurements to establish reference blood pressure. These observers are trained and certified according to specific protocols.)
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Qualifications of Experts: This information is not provided in the 510(k) clearance letter.
- (Hypothetical Example: "Two independent, trained and certified observers, typically nurses or clinical technicians, experienced in auscultatory blood pressure measurement. They underwent specific training and demonstrated proficiency and inter-observer reliability prior to the study, using a mercury sphygmomanometer with a Y-tube and dual stethoscope.")
4. Adjudication Method for the Test Set
- Adjudication Method: This information is not provided in the 510(k) clearance letter.
- (Hypothetical Example based on NIBP validation standards: For reference auscultatory blood pressure, the average of the two trained observers' readings is typically used, provided their readings are within a pre-defined tolerance (e.g., within 4 mmHg). If the difference exceeds this tolerance, a third observer might be used, or the measurement might be discarded.)
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: This type of study is typically performed for imaging devices where human interpretation is a key component, often comparing AI-assisted reading to unassisted reading. For a non-invasive blood pressure monitor, an MRMC study is not applicable as the device provides a direct measurement, not an interpretation of a complex image or signal requiring human-in-the-loop assessment in the same way. The validation focuses on the accuracy of the device's measurement compared to a reference standard.
- Therefore, no MRMC study was done or is relevant for this type of device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: For a non-invasive blood pressure monitor, the "standalone performance" refers to the accuracy of the device's measurement itself, without human intervention in the measurement process (beyond proper setup). The clinical validation study (as described hypothetically in section 1 and 2) is precisely a standalone performance assessment. The device measures blood pressure automatically and displays the result.
- Therefore, yes, a standalone performance study (i.e., the clinical validation study) was done to demonstrate the accuracy of the device's automatic measurements against a reference standard. The results would be compared against the acceptance criteria.
7. The Type of Ground Truth Used
- Type of Ground Truth: This information is not provided directly in the 510(k) clearance letter, but for NIBP devices, there's a standard method.
- (Hypothetical Example based on NIBP validation standards: The ground truth would be established by simultaneous, independent, trained-observer auscultatory measurements using a mercury sphygmomanometer (or an appropriately validated non-mercury reference device) with a bifurcated stethoscope, following strict protocol guidelines (e.g., those from ISO 81060-2 or AAMI). This method provides a "clinical reference standard".)
8. The Sample Size for the Training Set
- Training Set Sample Size: This information is not provided in the 510(k) clearance letter.
- For a device like this, the "training set" might refer to data used for algorithm development and calibration during the R&D phase. This is typically internal data not submitted as part of the 510(k) clinical validation study. The 510(k) focuses on the final, locked algorithm evaluated on an independent test set.
- Therefore, the concept of a "training set" sample size for the regulatory submission of an NIBP device's clinical performance is not directly applicable in the same way it would be for an AI/ML product where the model is continuously learned from data. The clinical validation uses a test set for the final device.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth: As explained above, for an NIBP monitor, the concept of a formally established "ground truth" for a "training set" in the context of a regulatory submission is not typically relevant. The device's algorithm for detecting oscillometric pulses and deriving SBP/DBP is developed using engineering principles and internal validation data during development.
- If any internal "training" or calibration data were used, the ground truth would likely have been established through a similar process as the clinical validation (i.e., comparison to reference auscultatory measurements) but for internal development and optimization purposes rather than regulatory demonstration of safety and effectiveness.
- This information is not provided and generally not required in a 510(k) for this type of device.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).